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Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

Primary Purpose

Refractive Errors, Astigmatism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hand-held device supported by a mobile application

Phoropter

Autorefractor

About this trial

This is an interventional diagnostic trial for Refractive Errors focused on measuring myopia, hyperopia

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or Female
Age 30 through 65 years at the time of consent
Binocular vision
Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)
Willing and able to give informed consent and follow all study procedures and requirements
Ability to speak and understand the English language

Exclusion Criteria:

Spherical correction > +8 or < -10
Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the device
Eye disease, including but not limited to:
- Glaucoma (≥ 22 mmHg intraocular pressure)
- Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III])
- Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)
- Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)
- Keratoconus
- Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)
- Cytomegalovirus retinitis
- Color blindness (any color deficiency)
- Diabetic macular edema (evidence of fluid)
- Amblyopia
- Chronic or acute uveitis (cells and/or flare in anterior chamber)
- Strabismus (exotropia, esotropia, and hypertropia)
- Abnormal astigmatism (mild to severe, > 5 diopters)
- Macular hole
Eye surgery within the last 12 months (including Lasik or lens replacement)
Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.

Sites / Locations

United Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Refraction with a Hand-held Device Supported by Mobile App.

Manual Refraction

Automated Refraction

Arm Description

BCVA with handheld device with app.

BCVA with phoropter

BCVA with autorefractoer

Outcomes

Primary Outcome Measures

BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years

Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.

Secondary Outcome Measures

Full Information

NCT ID

NCT03929588

First Posted

April 22, 2019

Last Updated

February 28, 2022

Sponsor

EyeQue Corp.

1. Study Identification

Unique Protocol Identification Number

NCT03929588

Brief Title

Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

Official Title

A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 7, 2019 (Actual)

Primary Completion Date

March 31, 2020 (Actual)

Study Completion Date

March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EyeQue Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Errors, Astigmatism

Keywords

myopia, hyperopia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.

Masking

ParticipantOutcomes Assessor

Allocation

Non-Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Refraction with a Hand-held Device Supported by Mobile App.

Arm Type

Experimental

Arm Description

BCVA with handheld device with app.

Arm Title

Manual Refraction

Arm Type

Active Comparator

Arm Description

BCVA with phoropter

Arm Title

Automated Refraction

Arm Type

Active Comparator

Arm Description

BCVA with autorefractoer

Intervention Type

Device

Intervention Name(s)

Hand-held device supported by a mobile application

Intervention Description

Hand-held device supported by a mobile application to obtain refractive error of the eye.

Intervention Type

Device

Intervention Name(s)

Phoropter

Intervention Description

Manual refraction and ETDRS chart

Intervention Type

Device

Intervention Name(s)

Autorefractor

Intervention Description

Automated refraction

Primary Outcome Measure Information:

Title

BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years

Description

Time Frame

Through study completion, an average of 5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or Female Age 30 through 65 years at the time of consent Binocular vision Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0) Willing and able to give informed consent and follow all study procedures and requirements Ability to speak and understand the English language Exclusion Criteria: Spherical correction > +8 or < -10 Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the device Eye disease, including but not limited to: Glaucoma (≥ 22 mmHg intraocular pressure) Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III]) Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula) Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis) Keratoconus Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy) Cytomegalovirus retinitis Color blindness (any color deficiency) Diabetic macular edema (evidence of fluid) Amblyopia Chronic or acute uveitis (cells and/or flare in anterior chamber) Strabismus (exotropia, esotropia, and hypertropia) Abnormal astigmatism (mild to severe, > 5 diopters) Macular hole Eye surgery within the last 12 months (including Lasik or lens replacement) Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Peace, MD

Organizational Affiliation

United Medical Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

United Medical Research Institute

City

Inglewood

State/Province

California

ZIP/Postal Code

90301

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

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